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Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the STERRAD® 100, 100S, NX® (Standard and Advanced cycles), 100NX® (Standard, Flex, Express and Duo cycles), AMSCO® V-PRO™ 1 (Lumen cycle), AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles), and AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) sterilizers. The chemical indicator bar turns from blue to pink after exposure to vaporized hydrogen peroxide.

The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 consists of a noncellulosic plastic material onto which a chemical indicator bar is printed. A comparison color match is also printed on the product to aid in color interpretation.

This document is a 510(k) premarket notification for a chemical indicator used in sterilization processes. It concerns the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248. The primary purpose of this 510(k) is to expand the indications for use of an already cleared device to include additional sterilizers (AMSCO® V-PRO™ 1, AMSCO® V-PRO™ 1 Plus, and AMSCO® V-PRO™ maX).

Here's an analysis based on the provided text:

Nature of the Device and Study:
This device is a chemical indicator, not an AI/ML powered medical device for diagnostic imaging or similar applications. It physically changes color (blue to pink) upon exposure to vaporized hydrogen peroxide during sterilization cycles to indicate successful processing. Therefore, many of the typical acceptance criteria and study methodologies asked for in AI/ML performance evaluations (like MRMC studies, standalone AI performance, large expert panels for ground truth of complex data, etc.) are not applicable to this type of device.

The "study" here refers to non-clinical testing to demonstrate the physical performance of the chemical indicator under specified sterilization conditions.

Acceptance Criteria and Device Performance Table:

Given the nature of the device, the acceptance criteria are based on the indicator's physical color change within specific sterilization cycle parameters. The document primarily focuses on demonstrating that the indicator performs identically to its predicate and successfully changes color within the new sterilizer cycles.

Since this is a simple chemical indicator and not an AI/ML software, many of the requested detailed points are not applicable or the information is not provided because it's not relevant to this type of device submission.

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: For the new sterilizer (AMSCO® V-PRO™ maX), "Samples from six different lots" were used for both "Color Change" and "Minimum Exposure Parameters" testing. Specific numbers of indicators per lot or per test run are not detailed in this summary.
   • Data Provenance: The data is from manufacturer testing ("Nonclinical Testing"). The country of origin is not explicitly stated, but the company (3M) is based in the USA, and the submission is to the FDA. This is considered prospective testing, specifically designed to demonstrate the device's performance under controlled conditions.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This is not applicable. The "ground truth" for a chemical indicator is its observable color change, verified against a printed color match. This is a physical, objective observation, not a subjective interpretation requiring expert consensus in the typical sense of medical image analysis. No human "experts" in the clinical sense were used to "establish ground truth" for the indicator's performance. The "ground truth" for whether the sterilizer cycle was appropriate comes from established sterilization parameters and validated equipment (which the indicator is designed to verify exposure to).

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This is not a study requiring reader adjudication. The color change is a direct physical property.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is not an AI/ML device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an AI/ML device. It is a passive chemical indicator.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" is the physical state of the chemical indicator (color change from blue to pink, validated against a color match on the product) and its performance under controlled and validated sterilization cycle conditions. It's an objective physical/chemical reaction.

7. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or a "training set."

8. How the ground truth for the training set was established:

   • Not applicable.

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